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Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US mRNA specialist Moderna today announced Health Canada has approved mRESVIA (respiratory syncytial virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
Biotechnology
GSK’s Arexvy (RSV vaccine) has received an expanded approval in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. 6 November 2024
Biotechnology
French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Pharmaceutical
Photocure, a Norway-based bladder cancer-focused company, has announced that Jiangsu Yahong Meditech, the parent company of its partner Asieris Pharmaceuticals, has received marketing authorization for Hexvix (hexaminolevulinate) in China. 5 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Pharmaceutical
Disc Medicine today announced a successful End of Phase 2 with the US Food and Drug Administration (FDA) supporting the regulatory path forward, including potential for accelerated approval, for bitopertin in erythropoietic protoporphyria (EPP). 4 November 2024
Pharmaceutical
On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine sugemalimab (trade name Eqjubi) to treat adult patients with a type of cancer called non-small cell lung cancer (NSCLC ). 31 October 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Pharmaceutical
Privately-held US drugmaker Protega Pharmaceuticals says that the US Food and Drug Administration (FDA) has approved Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 29 October 2024
Pharmaceutical
Shares of US drug developer Intercept Pharmaceuticals closed down 14.7% at $13.83 yesterday, after the US Food and Drug Administration released briefing document ahead of the FDA’s Gastrointestinal Drugs Advisory Committee. 18 May 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted Japanese pharma major Takeda’s Biologics License Application (BLA) for TAK-755, an enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP), an ADAMTS13 deficiency disorder, for priority review. 17 May 2023
Biotechnology
Scientists at the US Food and Drug Administration have outlined a positive stance towards an RSV vaccine developed by Pfizer, ahead of a formal meeting to discuss the firm’s regulatory submission for the candidate. 17 May 2023
Biotechnology
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), under development by Dutch clinical-stage biotech Byondis. 16 May 2023
Biotechnology
Medicines regulator Health Canada has accepted a New Drug Submission (NDS), submitted by Japan’s Eisai and US biotech Biogen, for Leqembi (lecanemab). 16 May 2023
Biotechnology
Adding to regulatory approvals in the USA and European Union, US pharma major Bristol Myers Squibb said today that its first drug in psoriasis, Sotyktu (deucravacitinib), has been granted Marketing Authorisation (MA) in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA). 15 May 2023
Biotechnology
UK-based RNA delivery and therapeutics company SiSaf has announced that SIS-101-ADO, its siRNA therapeutic for patients with autosomal dominant osteopetrosis type 2 (ADO2), has been granted orphan drug designation by the US Food and Drug Administration (FDA). 15 May 2023
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is preparing to publish an update on variable rates of access to new medicines in the region. 15 May 2023
Pharmaceutical
The US Food and Drug Administration on Friday finally approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. 15 May 2023
Pharmaceutical
A team of German Institute for Quality and Efficiency in Health Care (IQWiG) authors, together with Rita Banzi from the Italian Mario Negri Institute, analyzed the effects of the lack of evidence on orphan drugs at the European and national level. The conclusion is that the need for reform is great. 15 May 2023
Biotechnology
US biopharma firm Insmed held a meeting with analysts last Monday, when it unveiled a new research platform in the area of Duchenne muscular dystrophy and other diseases. Two M&A deals featured last week, first with US biotech major Gilead Sciences revealing the acquisition of XinThera, which will expand its early-stage oncology and inflammatory diseases portfolio. Also, Swedish Orphan Biovitrum (Sobi) announced it is acquiring US biotech CTI BioPharma, along with its hematology drug Vonjo, in order to expand its position in this rare disease sector. Meantime, US drugmaker Reata Pharmaceuticals reported a setback for its Friedreich’s ataxia drug Skyclarys with a New Drug Application (NDA) submitted to the Food and Drug Administration (FDA) to increase the drug substance specification for a process impurity observed above the current specification during process validation. 14 May 2023
Biotechnology
Friday turned out to be a positive day for Sarepta Therapeutics, with a narrow, but positive, regulatory advisory committee vote. 13 May 2023
Biotechnology
ImmunityBio lost 54% of its market value on Thursday. 12 May 2023
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday announced it is requiring sponsors of amphetamine and methylphenidate products, a class of stimulant medications used to treat attention deficit/hyperactivity disorder (ADHD) and other disorders, to update and standardize their prescribing information to clearly inform patients, caregivers and health care professionals of risks associated with their medications. 12 May 2023
Biotechnology
Shares in Texan pharma company Reata Pharmaceuticals closed 15% lower on Wednesday. 11 May 2023
Biotechnology
Recently-released US FDA briefing documents reveal an ambiguous response to data for a candidate developed by Sarepta Therapeutics. 11 May 2023
Pharmaceutical
Following a positive vote last month from the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee, the US Food and Drug Administration (FDA) has now approved the supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease. 11 May 2023
Biotechnology
The recent European Commission approval for Sotyktu (deucravacitinib), US pharma major Bristol Myers Squibb’s first-in-class, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for adults with moderate-to-severe plaque psoriasis (PsO), has elicited comment from a leading data and analytics firm. 11 May 2023
Pharmaceutical
French drugmaker Servier has secured European approval for Tibsovo (ivosidenib) in two indications, making it the first and only IDH1 blocker to be available in the region. 11 May 2023
Biotechnology
Alexion, a subsidiary of Anglo-Swedish pharma major AstraZeneca with a focus on rare diseases, has scored another win in neuromyelitis optica spectrum disorder (NMOSD). 10 May 2023
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